CrossRoads™ 3.5mm x 46mm Anti-Drift Bolt 15LP-3546

GUDID 00815432028887

The CrossRoads™ Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.

CROSSROADS EXTREMITY SYSTEMS

Surgical depth gauge, single-use

• Primary Device ID: 00815432028887
• NIH Device Record Key: 006e8437-1ead-4b05-9244-c3b61b41be5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CrossRoads™ 3.5mm x 46mm Anti-Drift Bolt
• Version Model Number: 15LP-3546
• Catalog Number: 15LP-3546
• Company DUNS: 058864308
• Company Name: CROSSROADS EXTREMITY SYSTEMS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com
• Phone: 901-221-8406
• Email: info@crextremity.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815432028887 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193452

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-19
• Device Publish Date: 2023-01-05

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